Relationship of Dopamine to Cognitive Function in Parkinson's Disease

NCT00094601 | Completed

• 2 other identifiers: 05001105-M-0011
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects. Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years of age may be eligible for this study. Pregnant women with Parkinson's disease and breastfeeding normal volunteers are excluded. Candidates are screened with a physical and neurological examination, blood tests, a brief mental test called the Mini Mental Status Examination, and other tests designed to assess memory, learning, reasoning, and other thought processes. Patients with Parkinson's disease also undergo a more thorough mental evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4 or 5 outpatient visits to NIH. Participants undergo two positron emission tomography (PET) scans on two separate days and a magnetic resonance imaging (MRI) scan, as follows: PET Scans The two PET procedures are done the same way, except one uses a radioactive tracer called \[(18)F\]DOPA and one uses a tracer called \[(11)C\]NNC-112. A catheter (small plastic tube) is placed in a vein in the subject's arm for injection of the tracer. The subject lies on the scanner bed and a special mask is fitted to his or her head to hold it in place during the procedure. Just before injecting the tracer, a 10-minute "transmission scan" is done of the head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers (\[(18)F\]DOPA or \[(11)C\]NNC-112 are done for about 90 minutes. About 1 hour before injection of the \[(18)F\]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the tracer work properly. Blood pressure, breathing and heart are monitored before and after injection of the \[(11)C\]NNC-112 tracer. Patients with Parkinson's disease are taken off all Parkinson's medications the night before the \[(18)F\]DOPA scan and their motor function is tested the following morning before the scans are done, using the Unified Parkinson's Disease Rating Scale. Patients can resume all medications except L-DOPA (including Sinemet) after the movement test, and they can resume L-DOPA after the PET scan is finished. MRI Scan MRI uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies still on a table that slides inside the scanner, a metal cylinder. They wear ear plugs to muffle loud knocking sounds that occur during the scanning and can communicate with the MRI staff at any time through an intercom.

Conditions

Parkinson Disease

Keywords

Positron Emission Tomograhy; [18F] FDOPA; [11C] NNC-112; Dopamine; Molecular Imaging; Dopamine D1 Receptor; PET; Parkinson's Disease; Cognition; Parkinson Disease; PD; Healthy Volunteer; HV

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD patients must meet the diagnosis of idiopathic Parkinson's disease. Diagnosis will be based upon the presence of at least two of the four cardinal symptoms (tremor, bradykinesia, rigidity and instability) as well as a positive response to dopaminergic agents.
• Patients will be on stable dopaminergic therapy for approximately two weeks prior to enrollment.
• Control subjects must be healthy and aged 40 - 85 years and will be age and gender matched to PD patients.

You may not qualify if:

• Diagnosis of idiopathic Parkinson's disease.
• Secondary cause of Parkinsonism, e.g. Wilson's disease, neuroleptic use.
• Psychiatric disease that would, in judgment of the investigator, interfere with the safe conduct of the study.
• Current psychiatric illness.
• Severe depressive symptoms with BDI 16+.
• Substance abuse, severe systemic disease, poor vision or hearing based on history and physical exam.
• Incidence of Parkinson's disease in two or more first degree relatives.
• Dementia not due to PD or severe dementia with MMSE less than 15.
• Neurological disorder other than PD that would effect protocol (e.g. stroke, Alzheimer's disease).
• Laboratory tests with clinically significant abnormalities.
• History of an abnormal MRI.
• Pregnancy or breast feeding.
• Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual NIH RSC limits.
• Any conditions that increase risk for MRI (pacemaker, metallic foreign body, claustrophobia, etc.).
• Any medical condition that in the opinion of the investigators would interfere with the safe conduct of the study.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Abi-Dargham A, Mawlawi O, Lombardo I, Gil R, Martinez D, Huang Y, Hwang DR, Keilp J, Kochan L, Van Heertum R, Gorman JM, Laruelle M. Prefrontal dopamine D1 receptors and working memory in schizophrenia. J Neurosci. 2002 May 1;22(9):3708-19. doi: 10.1523/JNEUROSCI.22-09-03708.2002.

  PMID: 11978847 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 20, 2004
• First Posted: October 21, 2004
• Study Start: October 18, 2004
• Study Completion: January 22, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-01-22

Locations

US (1)